Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community

This study has been completed.
Sponsor:
Collaborators:
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Ebbing Lautenbach, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00966446
First received: August 25, 2009
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the community and test an intervention to prevent MRSA transmission in this setting.

Condition Intervention
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Drug: Unsupervised Decolonization
Drug: Supervised Decolonization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Epidemiology and Prevention of MRSA Transmission in the Community

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Recurrent Infection [ Time Frame: Within 6 months ] [ Designated as safety issue: No ]
    Confirmed new MRSA infections

  • First Two Consecutive Sampling Periods Completed [ Time Frame: Within 2 months ] [ Designated as safety issue: No ]
    Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis


Secondary Outcome Measures:
  • Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization [ Time Frame: Within 6 months ] [ Designated as safety issue: No ]
    Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.


Enrollment: 223
Study Start Date: September 2009
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.
Drug: Unsupervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.
Other Name: Experimental: Unsupervised Decolonization
Experimental: Supervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Study staff is in contact with household members during this intervention to ensure compliance.
Drug: Supervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. In addition, households are contacted by study stuff via phone or text messages to ensure complicane, to provide reminders to household members to perform the decolonization protocol as well as to answer any question/concerns household members may have.
Other Name: Experimental: Supervised Decolonization
No Intervention: No Intervention
Households do not undergo active MRSA decolonization protocol

Detailed Description:

The overall goals of this project are to:

  1. to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant Staphylococcus aureus (MRSA) infections in community settings in order to reduce the burden of this illness in the State of Pennsylvania. This objective has the following specific aims:

    • to identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households.
    • to evaluate the impact of a decolonization intervention on MRSA infections in the household.
    • to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions.
  2. to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a Center of Excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies
  3. to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators
  Eligibility

Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled

Exclusion Criteria:

  • Prior MRSA within past 6 months in the index case; age less than 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966446

Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Ebbing Lautenbach
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Ebbing Lautenbach, MD University of Pennsylvania
  More Information

Responsible Party: Ebbing Lautenbach, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00966446     History of Changes
Other Study ID Numbers: 809899 
Study First Received: August 25, 2009
Results First Received: December 1, 2015
Last Updated: July 6, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
MRSA; household; infection; colonization

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016